This 4-year randomized controlled trial (RCT) aimed at investigating whether routine home use of both a SnCl2/AmF/NaF-containing mouth rinse and toothpaste has a preventive effect on oral health. Fifty-four test subjects were examined in biannual intervals. The primary endpoint "dental erosion" was determined by the Basic Erosive Wear Examination (BEWE). The secondary endpoints were "saliva pH", "dentin hypersensitivity" generated by Visual Analogue Scale (VAS), and "discoloration" measured by the Lobene Stain Index (LSI). A mixed model for repeated measures (MMRM) was used to analyze the primary endpoint "dental erosion". Primary analysis showed a significant intervention effect of the SnCl2/AmF/NaF-containing test product (p1 = 0.0242). This result was confirmed by two additional MMRM-based sensitivity analyses. Comparison of all models showed "dental erosion" values of the intervention group below values of the control group. Discoloration of the teeth was significantly higher in the intervention than in the control group at all time points. Saliva pH and dentin hypersensitivity were not significantly different between groups over four years. In summary, this RCT is the first to indicate a possible preventive effect of SnCl2/AmF/NaF-containing oral hygiene products on dental erosion over a follow-up period of four years.

中文翻译：

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含氟化亚锡和氟化胺胺的口腔卫生产品的临床效果：一项为期4年的随机对照试验研究。

这项为期4年的随机对照试验（RCT）旨在研究含SnCl2 / AmF / NaF的漱口水和牙膏的常规家庭使用是否对口腔健康具有预防作用。每半年检查54名测试对象。主要终点“牙齿侵蚀”是由基本侵蚀磨损试验（BEWE）确定的。次要终点是通过视觉模拟量表（VAS）产生的“唾液pH”，“牙本质过敏”和通过洛宾染色指数（LSI）测量的“变色”。重复测量的混合模型（MMRM）用于分析主要终点“牙齿侵蚀”。初步分析显示，含SnCl2 / AmF / NaF的受试产品具有显着的干预作用（p1 = 0.0242）。通过另外两个基于MMRM的敏感性分析证实了这一结果。所有模型的比较显示干预组的“牙齿侵蚀”值低于对照组的值。在所有时间点，干预组的牙齿变色均显着高于对照组。四年间，两组之间的唾液pH和牙本质过敏性没有显着差异。总之，该RCT首次表明了在四年的随访期内含SnCl2 / AmF / NaF的口腔卫生产品可能对牙齿侵蚀的预防作用。在所有时间点，干预组的牙齿变色均显着高于对照组。四年间，两组之间的唾液pH和牙本质过敏性没有显着差异。总之，该RCT首次表明了在四年的随访期内含SnCl2 / AmF / NaF的口腔卫生产品可能对牙齿侵蚀的预防作用。在所有时间点，干预组的牙齿变色均显着高于对照组。四年间，两组之间的唾液pH和牙本质过敏性没有显着差异。总之，该RCT首次表明了在四年的随访期内含SnCl2 / AmF / NaF的口腔卫生产品可能对牙齿侵蚀的预防作用。